EVALUATING CONTENT VALIDITY OF PERFORMANCE OUTCOMES (PERFOS)- ESTABLISHING THE PATIENT-RELEVANCE OF THREE PERFOS IN ELECTIVE TOTAL HIP REPLACEMENT (ETHR)

Author(s)

Ballinger RS1, Kerr C1, Bush EN2
1ICON, Oxford, UK, 2Eli Lilly, Indianapolis, IN, USA

OBJECTIVES: Performance Outcomes (PerfOs) measure tasks performed by a patient under the instruction of a health-care professional. PerfOs used to support FDA label claims now require content validity evidence. This study explored patient experience and relevance of three elective total hip replacement (eTHR) PerfOs: the timed up and go (TUG), four step stair climb (4SC) and long stair climb (LSC). METHODS: Eight recent eTHR patients in the US were interviewed by telephone within 7 days of completing three PerfOs. Participants discussed their experience of completing the PerfOs; and how the movements, speed and level of difficulty corresponded to activities in their everyday lives. Interviews were audio-recorded, transcribed and systematically coded. Saturation was assessed by tabulated patient summaries from which new elements reported in each interview were identified. RESULTS: The sample comprised six females and two males, with mean age 67 years. All participants related TUG movements to activities in their daily life (e.g. getting up to turn on the television) and most regularly climbed a few steps at home and in a similar way to the 4SC (e.g. use of handrail). Climbing 12 or more steps (LSC) was less common. However, the majority recalled examples of this and felt the LSC accurately reflected movement and ability in their replaced hip. Two participants reported LSC completion increased their confidence and staircase use. Small differences between PerfOs and everyday activities/function were reported (e.g. TUG: the type of chair and turning towards rather than away from the replaced hip). Assessment of saturation suggested additional interviews might yield further varieties in patient experience but that sufficient consensus and depth was achieved to understand the relevance of the PerfOs to everyday function. CONCLUSIONS: New methodological approaches developed to explore content validity of PerfOs demonstrate the connection between three PerfOs and daily function of eTHR patients.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PRM11

Topic

Clinical Outcomes

Topic Subcategory

Clinical Outcomes Assessment

Disease

Musculoskeletal Disorders

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